Comparison of Criteria for Liver Transplantation in Hepatocellular Carcinoma

NCT04576572 | Completed

• 1 other identifier: LT-Criteria-HCC
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular cancer is the 6th most common seen disease in the world and the 3rd in cancer-related deaths. Liver transplantation is the primary curative treatment of HCC, as it eliminates liver cancer and underlying cirrhosis. However, liver transplantation is not offered to every HCC patient, since advanced stage HCC patients are lost with tumor recurrence early after liver transplantation. The Milan criteria, which are accepted worldwide, are the patient selection criteria that we have to follow in cadaver-to-liver transplantation for HCC in our country. However, as the Milan criteria are very strict criteria, it pushes patients out of liver transplantation who exceed the Milan criteria but who can benefit from liver transplantation. Liver transplantation centers all over the world have declared their own criteria under the expanded Milan criteria. In our country, Malatya Criteria have been defined by İnönü University on this subject, and our studies on this subject still continue. When we scan the original articles of all these defined criteria, incomplete data are formed and therefore the strength of the criteria cannot be clearly revealed. For this reason, we aimed to analyze the results of our center and present information about the power of the criteria to the literature.

Conditions

Hepatocellular Carcinoma; Liver Cancer; Advanced Adult Hepatocellular Carcinoma; Cirrhosis, Liver; Unresectable Liver Cancer; Liver Transplant Disorder

Keywords

Hepatic malignancy; malignancy; living donor; liver transplantation; expanded criteria; extended; liver cancer

Outcome Measures

Primary Outcomes (3)

• Disease Free Survival

  Tumor free survival after liver transplantation

  five years

• Overall Survival

  Overall survival after liver transplantation

  five years

• Tumor recurrence

  Tumor recurrence following liver transplantation

  5 year

Secondary Outcomes (1)

• The Best Criteria

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between 2002 - 2020 August, patients undergone Liver Transplantation at Liver Transplant Institute of Inonu University.

You may qualify if:

• Patients undergone liver transplantation due to hepatocellular carcinoma
• Incidentally detected hepatocellular carcinoma at the explant pathology report

You may not qualify if:

• Patients with follow up period below 90 days
• Advanced Tumors which have lymph node positivity, main PV tumor thrombosis, adjacent tissue invasion defined by explant pathology etc.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Liver Transplantation Institute, Inonu University

Malatya, Battalgazi, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Liver Cirrhosis; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Volkan Ince, MD

  Inonu University, Liver Transplant Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: June 15, 2020
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 01.01.2022

Locations

TU (1)